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Infliximab in Polymyositis/Dermatomyositis/Inclusion Body Myositis

Principal Investigator:

Ingrid Lundberg, Karolinska Institute

Study Design:

Phase 2 Open trial, Infliximab dose 5 mg/kg

Types & Number of IIM Studied:

Active Polymyositis/Dermatomyositis/Inclusion Body Myositis with reduced muscle function (N = 15)

Entry Criteria:

Refractory to prednisolone and methotrexate

IMACS Core Set Measures Included:

Physician and Patient Global Activity and Damage Assessments, Health Assessment Questionnaire, Manual Muscle Testing, muscle enzymes, Myositis Disease Activity Assessment Tool; Myositis Damage Index, Health-Related Quality of Life by SF-36

Other Measures Included:

Myositis Functional Index, aerobic capacity, biopsies

Primary Outcome:

Improved functional index and decreased inflammation in muscle biopsies

Study Duration:

16 weeks

Funding:

Schering Plough

Comments:

Started in 2003. Enrollment completed.

Publications:

Dastmalchi M1, Grundtman C, Alexanderson H, Mavragani CP, Einarsdottir H, Helmers SB, Elvin K, Crow MK, Nennesmo I, Lundberg I. A high incidence of disease flares in an open pilot study of infliximab in patients with refractory inflammatory myopathies., Ann Rheum Dis, 2008 Dec;67(12):1670-7.[Abstract ]

Contact:

Ingrid Lundberg, M.D., Ph.D.
Rheumatology Unit
Department of Medicine
Karolinska University Hospital
Solna, Karolinska Institutet
SE- 171 76 Stockholm, Sweden
Tel +46-8-5177-3080
Fax +46-8-5177-3080
Ingrid.Lundberg@medks.ki.se


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